a study, combination, immunologic study of ltx-315 as adjunct to gv1001 in patients following curative surgery for carcinoma

Conditions: Carcinoma

Summary: this study involves testing of the medicine ltx-315 combined with a cancer vaccine (gv1001). this will be tested in patients that have had surgery with curative intent for malignant tumour. gv1001 is a peptide vaccine in development to treat cancer. an adjuvant, is required to start the immune response in the body to have effect of gv-1001. ltx-315, also a peptide, in development for cancer treatment. in this study, the investigators wish to find out whether ltx-315 can make gv1001 more effective at stimulating the immune system.

this clinical study has two main aims which are: * to measure the immunological effects of ltx-315 in combination with gv1001 * find out about the side effects of the combination of the two drugs this is an open label, single centre study assessing immunological effects and safety of ltx-315 given as an adjunct to gv1001. the ltx-315 dose will escalate while the gv1001 dose will be fixed. ltx-315 and gv1001 will be given as intradermal injections on days 1, 8, 15, 22 and 36. investigational treatment: ltx-315 (0.10 ml) with escalating concentrations will be injected intradermally, followed, 1-2 hours later, by intradermal injection of 0.56 mg gv1001 (0.20 ml, 2.8 mg/ml) in the same site, in one arm. dth-test control: 0.10 mg gv1001 (0.10 ml) will be injected intradermally in the contralateral arm without ltx-315, as a dth skin reactivity test control.

Eligibility criteria:
inclusion criteria: * curative surgery for carcinoma performed at least three months prior to treatment start * age ≥18 years * ecog performance status (ps): 0 * life expectancy: at least 3 months * laboratory requirements: * white blood count (wbc) ≥ 3 x 109/l * absolute neutrophil count (anc) ≥ 1.5 x 109/l * platelet count ≥ 100 x 109/l * haemoglobin ≥ 10.0 g/dl * total bilirubin level ≤ 1.5 uln * ast and alt ≤ 2.5 x uln * creatinine ≥ 1.5 uln * albumin \> 30 g/l * no expectation of anti-cancer therapy or immunotherapy during the trial period, hormone therapy given as adjunctive or contraceptive therapy is permitted * must be willing to practice acceptable barrier methods of birth control to prevent pregnancy * the patient is willing and able to comply with the protocol and agrees to return to the hospital for follow-up visits and examination * the patient has been fully informed about the study and has signed the informed consent form exclusion criteria: * has received an investigational drug within 4 weeks prior to study drug administration, or is scheduled to receive one during the treatment or the post-treatment period * has received immunotherapy or been vaccinated within 12 weeks prior to study drug administration or has not recovered from adverse events due to such agents * has received external radiotherapy or cytotoxic chemotherapy within the last 4 weeks prior to study drug administration, or has not recovered from adverse events (\< grade 1) due to agents administered more than 4 weeks earlier * has received imiquimod within 12 weeks prior to study drug administration or has not recovered from associated adverse events * is currently on any agent with a known effect on the immune system * has any other serious illness or medical condition such as but not limited to: * any uncontrolled infection or infection requiring antibiotics * uncontrolled cardiac failure classification iii or iv (new york heart association) * uncontrolled systemic and gastro-intestinal inflammatory conditions * bone marrow dysplasia * history of auto-immune disease * history of adverse reaction to vaccines * known history of positive tests for hiv/aids, hepatitis b or c * is pregnant or breastfeeding

Keywords: cancer carcinoma curative surgery curative surgery for carcinoma at least three months and not more than 5 years prior to treatment start